Reported Apr 16, 2014 · Terminated
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East…
Zions RX Formulations Services LLC dba RX Formuations Serv.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zions RX Formulations Services LLC dba RX Formuations Serv. · 5949 E University Dr · Mesa, AZ · 85205-7435
Is this the product you have?
- Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Lot codes and dates
- Lot #: 117456@3
- Expiration Date12/12/2013 Lot #: 117907@3
- Expiration Date12/19/2013 Lot #: 118297@8
- Expiration Date12/25/2013
- Amount recalled
- 60 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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